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临床试验/NCT02914496
NCT02914496进行中(未招募)不适用

"Diabetes in Balance" - a Randomized Controlled Trial to Evaluate the Effects on Glucose Control, Self-care and Psychosocial Factors?

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2016年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
81
试验地点
2
主要终点
HbA1c

研究概览

简要总结

For many people living with type 1 diabetes it is a challenge to achieve good glucose control. Barely 20% reaches the goal level and many people experience self-care as complex, demanding and stressful. The purpose of this study is to evaluate the effect of a stress-management program on glucose control, self-care and psychosocial factors. The program is based on Acceptance and Commitment Therapy (ACT), a specific form of Cognitive behavior therapy (CBT). A total of 70 adult patients with type 1 diabetes from Ersta hospital will be recruited. Half of them will receive the intervention and the other half will continue with their regular diabetes care. A licensed psychologist specialised in CBT and a diabetes specialist nurse will be leading the intervention that is given in a group format. The program consists of seven 2-hour sessions given over 14 weeks. Glucose control, self care and stress will be measured at inclusion, after session four and seven, at six , 12 and 24 months and finally after 5 years

详细描述

ACT-stress management in type 1 diabetes - a randomized controlled trial to evaluate the effect on glucose control, self-control and psychosocial factors.

Purpose of proposed investigation:

The project hypothesis are that the CBT-intervention will a) improve glucose control, self-care, quality of life and acceptance of diabetes related thoughts and emotions and b) decrease depression, anxiety, general and diabetes related distress and fear of hypoglycemia.

Background information for the project:

The overall goal of diabetes management is to achieve good glycemic control while still maintaining good quality of life and experiencing as few hypoglycemic episodes as possible (the Swedish Social Board of Welfare, 2010). Currently only 19% of people with diabetes reach the goal of 52 mmol/mol for glycemic control (National Diabetes Registry, 2014). Research has proposed difficulties with behavior change (Knight et al., 2006), diabetes related distress (van Bastelar et al., 2010, Fisher et al., 2010) and fear of hypoglycemia (Wild et al., 2007) as important obstacles in achieving the goal. Patient education plays an important role in diabetes care but may not be sufficient in order to reach the recommended treatment goals. The association between knowledge and behavior change is weak and research has suggested that interventions should be more behavior oriented (Knight et al., 2006, Funnell et al., 2008). It is well known that people with chronic disease have an increased risk of developing psychological problems, for instance there are studies showing up to four times higher prevalence of depression in people with type 1 diabetes (Roy & Lloyd, 2012). It is also known that psychological problems are associated with poorer glycemic control, health and quality of life in this group (Chiechanowski et al., 2000; Jacobson, 2004).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 diabetes
  • Duration of disease >2 years -
  • Hb1c>60 mmol/mol

排除标准

  • Insufficient knowledge to understand and express themselves in Swedish
  • Untreated or severe ongoing psychiatric disease
  • Cortisone treatment
  • Untreated thyroid disease
  • Insulin pump therapy started since <3 months

结局指标

主要结局

HbA1c

时间窗: 12 months post inclusion

Measure of long term glucose control

次要结局

  • The Hypoglycemia Fear Survey emotions, depression, anxiety, fear of hypoglycemia, general and diabetes related distress.(1-5 years post inclusion)
  • The Problem Areas in Diabetes (Swe-PAID-20) Scale(1-5 years post inclusion)
  • Manchester Short Assessment of Quality of life(1-5 years post inclusion)
  • Depression Anxiety stress scales(1-5 years post inclusion)
  • The Summary of Self-Care Activities(1-5 years post inclusion)
  • Acceptance and action diabetes questionnaire(1-5 years post inclusion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Toft

Associate Professor

Karolinska Institutet

研究点 (2)

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